BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II IMPLANTABLE PUMP

    MDR report key: 3060243 · Received April 9, 2013

    Report

    Report Number
    MW5029756
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH MULTIPLE SCLEROSIS SINCE 1994 HAS BEEN MANAGING HER SPASTICITY WITH MEDTRONIC SYNCHROMED II IMPLANTABLE INTRATHECAL PUMP SINCE 2008 WITHOUT ANY PROBLEM. ON (B)(6) 2013 THE PT HAD ROUTINE PUMP REFILL WITHOUT ANY CHANGES PROGRAMMED. THE PROCEDURE WAS DONE BY THE MOST EXPERIENCED PERSONNEL IN THE CLINIC WITHOUT PROBLEMS. NEXT DAY THE PT WAS ADMITTED TO ED WITH AMS AND HYPOTENSION. SHE WAS NEARLY COMATOSE AND REQUIRED INTUBATION. NO SEIZURE ACTIVITY WAS OBSERVED. UDM WAS NEGATIVE. HEAD CT WAS NEGATIVE. BLOOD WORK WAS ALL NEGATIVE. NO S/S OF INFECTION WAS NOTED. THE PUMP WAS IMMEDIATELY INTERROGATED, BUT NO ERRORS/EVENTS WERE NOTED. THE DAILY DOSE WAS DECREASED BY 65 PERCENT. THE PT IMPROVED ENOUGH TO BE EXTUBATED LATER, BUT REMAINED EXTREMELY SOMNOLENT AND DROWSY. SHE HAD PROFOUND DECREASE IN MUSCLE TONE. PUMP WAS REPROGRAMMED TO EVEN LOWER DAILY DOSE OF 80 MCG/DAY. MRI OF THE HEAD AND BRAINSTEM WAS POSITIVE WITH FINDINGS CONSISTENT WITH MS, THAT WERE NOT NEW. FINALLY THE PUMP WAS EMPTIED AND WAS FOUND TO HAVE 6ML LESS IN THE RESERVOIR THAN WAS INDICATED IN THE INTERROGATED SETTINGS. THE PUMP WAS PROMPTLY REPLACED WITH ANOTHER SYNCHROMED II DEVICE IN THE OPERATING ROOM. SHE REMAINED INTUBATED OVERNIGHT. SHE WAS SUCCESSFULLY EXTUBATED AND HAD MARKED IMPROVEMENT IN HER MENTAL STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144511 SYNCHROMED II IMPLANTABLE PUMP BACLOFEN PUMP LKK MEDTRONIC SYNCHROMED II

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| O| R| S CLONIDINE 75MCG/ML| BACLOFEN 270 MCG/DAY